STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis

Exclusion Criteria

• •1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 months or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer or in situ cancer that does not require further active treatment or is well under control
• •2. Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GVHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant.
• •3. Must be off calcineurin inhibitors for at least 4 weeks prior to study treatment.
• •4. New York Heart Association (NYHA) class greater than or equal to 3
• •5. Left ventricular ejection fraction (LVEF) \< 40%.
• •6. The following baseline chemistry laboratory results at Screening:
• •1. Serum creatinine \> 2.0 x the upper limit of normal (ULN), or estimated creatinine clearance \< 60 mL/min (using the Cockcroft-Gault equation).
• •2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x the upper limit of normal (ULN) or serum total bilirubin \> 1.5x ULN (except for patients in or leukemia involvement)
• •7. Pregnancy or currently breastfeeding
• •8. Patients with greater than Grade 3 neuropathy or Grade 2 neuropathy with associated pain
• •9. Active bacterial, viral, or fungal infection at the time of the infusion of STI-6129; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents, or infection controlled on antimicrobial agents remain eligible as long as there is no evidence of active infection
• •10. Uncontrolled human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test.
• •11. Have a prolongation in QTcF (Fridericia correction formula) \> 480 msec on a baseline ECG
• •12. Any condition including the presence of laboratory abnormalities that places the patient at an unacceptable risk if the patient was to participate in the study